Orion Group Financial Statement Release for 2021

This is a summary or Orion’s Financial Statement Release for 2021. The complete report is attached to this stock exchange release and is available at https://www.orion.fi/en/Orion-group/investors/financial-reviews-and-presentations/

• Net sales totalled EUR 1,041 million (EUR 1,078 million in 2020).
• Operating profit was EUR 243 (280) million.
• Profit before taxes was EUR 242 (278) million.
• Equity ratio was 68% (67%).
• ROCE before taxes was 29% (35%).
• ROE after taxes was 26% (29%).
• Basic earnings per share were EUR 1.38 (1.56).
• Cash flow per share before financial items was EUR 0.96 (1.85).
• The Board of Directors proposes payment of a dividend of EUR 1.50 (1.50) per share.
• Orion estimates that net sales in 2022 will be at a similar level as in 2021 (net sales in 2021 were EUR 1,041 million). Operating profit is estimated to be at a similar level as in 2021 (operating profit in 2021 was EUR 243 million).

KEY FIGURES

	10-12/21	10-12/20	Change %	1-12/21	1-12/20	Change %
Net sales, EUR million	276.5	255.4	+8.3%	1,041.0	1,078.1	-3.4%
EBITDA, EUR million	52.6	47.8	+10.1%	289.1	336.5	-14.1%
% of net sales	19.0%	18.7%		27.8%	31.2%
Operating profit, EUR million	39.9	34.2	+16.7%	243.3	280.1	-13.1%
% of net sales	14.4%	13.4%		23.4%	26.0%
Profit before taxes, EUR million	39.8	33.8	+17.9%	242.3	278.3	-12.9%
% of net sales	14.4%	13.2%		23.3%	25.8%
Profit for the period, EUR million	32.8	25.5	+28.8%	193.8	219.9	-11.9%
% of net sales	11.9%	10.0%		18.6%	20.4%
R&D expenses, EUR million	41.0	38.4	+6.9%	117.7	123.2	-4.5%
% of net sales	14.8%	15.0%		11.3%	11.4%
Capital expenditure, EUR million	19.5	18.0	+8.2%	85.4	48.5	+76.0%
% of net sales	7.0%	7.1%		8.2%	4.5%
Interest-bearing net liabilities, EUR million				-108.3	-185.8	-41.8%
Basic earnings per share, EUR million	0.23	0.18	+28.7%	1.38	1.56	-11.9%
Cash flow per share before financial items, EUR	0.44	0.33	+34.4%	0.96	1.85	-47.8%
Equity ratio, %				68.1%	66.7%
Gearing, %				-14.5%	-25.4%
ROCE (before taxes), %				28.8%	34.8%
ROE (after taxes), %				26.2%	29.1%
Average personnel during the period				3,364	3,337	+0.8%

President and CEO Timo Lappalainen:
Again a strong performance by Orion amidst the pandemic – many good news from development projects

“In 2021, Orion and its employees once again performed well as the COVID-19 pandemic continued and affected our operating environment in many ways. Our primary goals have been looking after the health and safety of our employees, ensuring production continuity and product availability, and safeguarding patient safety in ongoing clinical trials. Amidst all this, we also received many good news from our development projects. Our performance was strong under the prevailing conditions, for which I would like to extend heartfelt thanks to all Orion employees and all our partners.

Orion's net sales was slightly lower and operating profit lower than in 2020. The trend was anticipated and is mainly explained by three factors: the milestone payments that were clearly smaller than in the comparison period, a drop in the sales of Dexdor® and Simdax® owing to the expiration of their product protection, and the expiration of a significant distribution agreement for veterinary drugs in the previous year. In other respects, the business achieved strong development in many areas, thereby mitigating the anticipated decline in consolidated net sales and operating profit. Excluding milestone payments, our operating profit was on par with previous year.

Although total net sales decreased year-on-year, we saw positive developments in many areas in 2021. Net sales of the Nubeqa® product booked by Orion continued strong growth as expected throughout the year. The Animal Health unit suffered from the termination of a significant distribution agreement, but excluding that impact, the unit's net sales saw a healthy rise of about 20 per cent. Thanks to a robust year-end, the Specialty Products unit reached modest growth, a commendable outcome under the circumstances where generic drug prices continue to fall. The Easyhaler® portfolio suffered from pandemic-related restrictions in the first half of the year, but eventually achieved small growth due to a robust second half of the year. In addition, the sales of Simdax® exceeded expectations, as the product did not yet face direct generic competition – i.e. competition with identical formulation – in most markets in 2021. The fall in Dexdor® product sales, on the other hand, was tempered by the continued pandemic and the resulting unusually high demand for sedatives throughout the year. The sales of Orion's Parkinson's disease drugs were at our anticipated medium-term level. Demand for Fermion products has remained good, and production has been running at nearly full capacity.

In 2021, we received good news from our research and development projects on several occasions. The most significant piece of news came in December, as the ARASENS trial, the clinical trial carried out in cooperation with Bayer to assess darolutamide as a treatment for metastatic hormone-sensitive prostate cancer, met its primary endpoint. More detailed trial results will be released in the near future. In addition, we launched the new ARANOTE trial on darolutamide with Bayer in the spring. In the summer, the veterinary drugs Bonqat® and Tessie® developed by Orion received marketing authorisation from the European Commission, and positive results were reported from the VIRPI trial, which examined the effects of virtual therapy in the treatment of chronic low back pain. In the autumn we launched a new Phase I clinical trial on tasipimidine (ODM-105), investigating the tolerability and safety of the molecule in healthy volunteers. The molecule is intended for the treatment of psychiatric disorders. At the end of the review period, we made the choice between two novel selective hormone synthesis inhibitors (CYP11A1 inhibitors), ODM-208 and ODM-209, and decided to focus our efforts on ODM-208. We are currently looking for a partner for the development and commercialisation of the molecule, as well as preparing to start the Phase III clinical trial.

We have worked hard for Orion's future by scouting new cooperation opportunities and new product and business acquisition targets. In 2021, we signed a European-wide marketing and distribution agreement with the US company Marinus Pharmaceuticals for ganaxolone, signed an early phase research collaboration and licencing agreement with Alligator Bioscience from Sweden, and launched research collaboration with the Finnish Red Cross Blood Service to develop CAR T-cell therapy. We have continued our geographic expansion beyond Europe, and Orion now has established sales functions in five Asia-Pacific countries. Additionally, production investments were at a higher level than in the preceding years. Systematic work to promote growth will also continue this year.

The disruption risk in global supply and logistic chains has been elevated for two years now, and there is no immediate relief in sight to this situation. Orion has succeeded in managing the supply chain risks by increasing inventory levels, among other measures. Due to worldwide operational bottlenecks, the prices of raw materials and logistics have increased, and there is continued price pressure. For Orion, the increase in costs is particularly challenging, as raising the prices of prescription medicines for human use in Orion’s markets is often not an option.”

Outlook for 2022

Orion estimates that net sales in 2022 will be at a similar level as in 2021
(net sales in 2021 were EUR 1,041 million).

Operating profit is estimated to be at a similar level as in 2021
(operating profit in 2021 was EUR 243 million).

Basis for outlook in more detail

Collaboration agreements with other pharmaceutical companies are an important component of Orion’s business model. Agreements often include payments recorded in net sales and operating profit that vary greatly from year to year. Forecasting the timing and amount of these payments is difficult. In some cases they are conditional on terms such as research outcomes which are not known until studies have been completed, the progress of research projects or the attainment of specified sales levels. On the other hand, neither the outcome nor the schedule of contract negotiations is generally known before the final signing of the agreement.

Milestone payments received by Orion in 2017-2021

Year	2017	2018	2019	2020	2021
EUR Million	12	5	51	42	3

The outlook for 2022 does not include any material milestones. Orion is currently looking for a partner for further development and commercialisation of its ODM-208 molecule research and a digital therapy software solution for treating chronic pain. The outlook does not contain any potential milestone payments associated with these projects, as the company does not yet have assurance of finding any partners or of the financial structure of any agreements to be made. Orion is entitled to receive milestone payments from Bayer for Nubeqa sales when certain global annual sales thresholds are met for the first time. Such milestone payments are not included in the outlook for 2022, as Orion does not have the ability to accurately estimate or predict the timing when the sales thresholds potentially are met.

The outlook is based on the assumption that Orion’s own production can continue to operate normally despite the COVID-19 pandemic and the challenges in the global supply chains. This requires, among other things, continued success in employee protection so that absence rates do not significantly increase, that personal protective equipment, supplies, equipment and spare parts needed in production as well as starting materials, intermediate products and materials are available and that there are no material disruptions in the logistics chains.

The outlook does not include any income or expenses associated with possible product or company acquisitions.

Net sales

Regarding Proprietary Products, the outlook anticipates that the net sales of Nubeqa® booked by Orion will clearly increase in 2022. Orion’s estimate is based on forecasts received from its partner Bayer. The sales of the Easyhaler® product portfolio is estimated to increase slightly. The sales of Orion’s branded Parkinson’s drugs (Comtess®, Comtan® and Stalevo®) are estimated to remain at the same level as in the previous year.

The COVID-19 pandemic significantly increased the demand for the intensive care sedative Dexdor® in 2020 and 2021, as a result of which the impact of generic competition on its sales did not fully materialise. Although the demand for intensive care sedatives remains elevated due to the pandemic, a clear decline in the net sales of the Dexdor® product is expected to continue in 2022. However, uncertainty prevails in this respect due to the pandemic.

Net sales of Simdax® are estimated to clearly decrease due to generic competition. Nevertheless, uncertainty still prevails as to when direct generic competition begins and how significantly the prices will drop.

The Specialty Products unit, meaning generic drugs and self-care products, accounts for a significant share of Orion's total sales. The outlook assumes that the COVID-19 pandemic will no longer materially affect the demand for generic drugs in 2022, although some customers may start using the stockpiles they had accumulated earlier in the pandemic. The outlook assumes that Orion will be able to increase its generic drugs sales volume, but foresees a simultaneous continued decline in generic drug prices. As a consequence, net sales of the Specialty Products unit are expected to be on par with the preceding year. The estimate does not include any impact of material supply disruptions or product shortages.

Net sales of Orion's Animal Health unit are expected to be on par with the preceding year. Net sales are weighed down by the termination of one distribution agreement in Finland, but products whose demand is increasing are expected to counterbalance the lost sales.

Fermion has been operating at very near full capacity over the past few years. The share of manufacturing of the active pharmaceutical ingredients of Orion's own proprietary drugs is estimated to increase, and consequently Fermion's external net sales reported by Orion are estimated to slightly decline in 2022.

Operating profit

Orion’s operating profit will be weighed down in 2022 by the falling sales of proprietary drugs Dexdor® and Simdax® due to generic competition. Relative gross margin is estimated to decline, as production costs, including wages, and the prices of raw materials, goods and services rise, and these price increases cannot be passed through to Orion's product prices. On the contrary, the prices of generic drugs are estimated to continue on a downward path despite rising costs. This development will negatively affect Orion's operating profit in 2022.

Operating expenses are estimated to increase from 2021. The impact of the COVID-19 pandemic kept operating expenses below normal in 2020–2021. The outlook presupposes that the pandemic will no longer affect costs with equal force in the second half of 2022. At the same time, increasing investments are made in the sales and marketing of products that are experiencing growth as well as new products, such as ganaxolone. Research and development expenses are estimated to be on par with or slightly higher than in 2021. Products whose demand is increasing, such as Nubeqa®, are expected to be able to offset the decrease in operating profit due to the above reasons; therefore, Orion estimates its operating profit to be at a similar level as in 2021.

Capital expenditure

The Group’s total capital expenditure in 2022 is expected to be on par with 2021 levels, when capital expenditure was EUR 85 million. Investments in 2021 included the EUR 25 million signing fee paid to Marinus for the sales and marketing rights to ganaxolone. In 2022, the grand total of investments will be raised by the revamping of Orion's Enterprise Resource Planning (ERP) system and renovation of the company's head office in Espoo, both scheduled for 2021-23.

Near-term risks and uncertainties  

The outlook is based on the assumption that Orion’s own production can continue to operate normally despite the COVID-19 pandemic and the challenges in the global supply chains. The sales of Orion-manufactured products depend on the ability of production and the entire supply chain to operate at the planned level. This involves numerous risks that may cause even material production disruptions. Such risks include the infection of employees, poor availability of personal protective equipment, supplies, equipment and spare parts, deteriorating availability of starting materials and intermediate products as well as logistics chain disruptions.

The outlook assumes that sales of Orion's Parkinson's drugs Stalevo® and Comtan® to its partner Novartis in Japan will not differ greatly from the preceding year. However, the outlook contains a degree of uncertainty due to potential generic competition or a decline in prices.

The basic patents for Dexdor® and Simdax® have expired and generic competition on these products has begun. In 2020–2021, the COVID-19 pandemic strongly increased the demand for intensive care sedatives, and therefore the sales of Dexdor® decreased during the period far less than anticipated. Its sales are estimated to decrease clearly in 2022, but this estimate is subject to uncertainty due to the pandemic situation. Generic competition to Simdax® started in the first markets in 2020 with a different formulation. Direct generic competition with a similar formulation has not yet commenced. In 2022, net sales of Simdax® are estimated to decrease clearly, but this estimate is subject to uncertainty. Actual sales will be affected, among other things, by the timing of the beginning of direct generic competition in the various markets and the intensity of this competition.

Sales of individual products and also Orion’s sales in individual markets may vary, for example depending on the extent to which the ever-tougher price and other competition prevailing in pharmaceutical markets in recent years will specifically focus on Orion’s products. Product deliveries to key partners are based on timetables that are jointly agreed in advance. Nevertheless, they can change, for example as a consequence of decisions concerning adjustments of stock levels. In addition, changes in market prices and exchange rates affect the value of deliveries. The COVID-19 pandemic significantly increased the demand for some Orion products especially in 2020, partly because customers increased their safety stocks. The dismantling of such safety stocks may have a momentary negative effect on the demand of Orion products. However, Orion is unaware of how much additional safety stocks customers have remaining and when customers might start using inventories that exceed normal stock levels. Due to the pandemic and various pandemic-related restrictions, the prevalence of many seasonal illnesses has been below normal, whereby the numbers of medical appointments and prescriptions issued have also declined. Non-critical procedures have also been postponed due to the pandemic. These phenomena have negatively impacted the development of the entire pharma market. At present, it is difficult to estimate how long the situation will last or to what extent the eventual waning of the pandemic will manifest as a release of any pent-up demand.

Currently no single currency is posing a material exchange rate risk for Orion. In Orion’s total net sales, the share of invoicing in US dollars has fallen to around ten per cent. At the same time, the value of purchases in dollars has increased. The weight of the US dollar will increase due to increasing sales of Nubeqa®. Other key currencies that carry an exchange rate risk are European currencies, including the Swedish krona and Norwegian krone and the British pound. However, the overall effect of the risk arising from currencies of European countries will be abated by the fact that Orion has organisations of its own in most European countries, which means that in addition to sales income there are also costs in these currencies. The exchange rate performance of the Japanese yen is significant due to sales of Parkinson’s drugs in Japan. The exchange rate effect related to the Russian rouble arises in particular due to the strong volatility of the currency. However, Russian sales do not represent a significant portion of Orion’s entire net sales.

Orion’s broad product range may cause risks to the delivery reliability and make it challenging to maintain the high quality standard required in production. The impacts of the COVID-19 pandemic and other challenges in the global supply and logistics chains of pharmaceuticals have increased the already elevated risk of supply disruptions. Moreover, the disruptions, production volume changes and logistical challenges experienced in other industries may also have unexpected and sudden ramifications that can manifest as shortages of necessary raw materials, supplies and equipment in the chemical and pharmaceutical industries and as increases in prices. The rise of raw material prices and other supply chain costs deteriorates the profitability of Orion's products, since in the pharmaceuticals industry it is virtually impossible to pass through the cost increases to own product prices, especially in Europe. The impacts of the COVID-19 pandemic on the availability of Orion's products have not been significant in 2021, but the risk of poorer than normal product availability remains elevated also in 2022.

Authorities and key customers in different countries carry out regular and detailed inspections of drug development and manufacturing at Orion’s production sites. Any remedial actions that may be required may at least temporarily have effects that decrease delivery reliability and increase costs. Orion’s product range also contains products manufactured by other pharmaceutical companies and products that Orion manufactures on its own but for which other companies deliver active pharmaceutical or other ingredients. Orion’s product range also contains products manufactured by other pharmaceutical companies and products that Orion manufactures on its own but for which other companies supply active pharmaceutical or other ingredients and components or parts (among these the Easyhaler® products). Possible problems related to the delivery reliability or quality of the products of those manufacturers may cause a risk to Orion’s delivery reliability. The single-channel system used for pharmaceuticals distribution in Finland, in which Orion’s products have been delivered to customers through only one wholesaler, may also cause risks to delivery reliability.

Research projects always entail uncertainty factors that may either increase or decrease estimated costs. The projects may progress more slowly or faster than assumed, or they may be discontinued. Nonetheless, changes that may occur in ongoing clinical studies, for example due to the COVID-19 pandemic, are reflected in costs relatively slowly and are not expected to have a material impact on earnings in the current year. Owing to the nature of the research process, the timetables and costs of new studies that are being started are known well in advance. They therefore typically do not lead to unexpected changes in the estimated cost structure. Orion often undertakes the last, in other words Phase III, clinical trials in collaboration with other pharmaceutical companies. Commencement of these collaboration relationships and their structure also materially affect the schedule and cost level of research projects.

Collaboration arrangements are an important component of Orion’s business model. Possible collaboration and licensing agreements related to these arrangements also often include payments to be recorded in net sales that may materially affect Orion’s financial results. In 2014–2021 the annual payments varied from EUR 3 million to EUR 51 million. The payments may be subject to conditions relating to the progress of research projects or sales or to new contracts to be signed, and whether these conditions or contracts materialise and what their timing is will always entail uncertainties.

Proposal by the Board of Directors: dividend EUR 1.50 per share

The parent company’s distributable funds are EUR 470,557,071.27, or EUR 3.35 per share. This includes EUR 204,676,467.01, or EUR 1.46 per share, of profit for the financial year. These per share amounts are calculated excluding treasury shares held by the Company. The Board of Directors proposes payment of a dividend of EUR 1.50 (1.50) per share from the parent company’s distributable funds.

No dividend shall be paid on treasury shares held by the Company on the dividend distribution record date. On the day when the profit distribution was proposed, the number of shares conferring entitlement to receive dividend totalled 140,562,964, on which the total dividend payment would be EUR 210,844,446.00. The Group’s payout ratio for the financial year 2021 would be 108.8% (95.9%). The dividend payment date would be 1 April 2022, and shareholders registered in the Company’s shareholder register on 25 March 2022 would be entitled to the dividend payment.

The Board of Directors further proposes that EUR 350,000 (350,000) be donated to medical research and other purposes of public interest in accordance with a separate decision by the Board and that EUR 259,362,625.27 remain in equity.

News conference and conference call

A webcast and a conference call for analysts, investors and media will be held on Thursday, 10 February 2022 at 13.30 EET. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion's website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.

To participate the conference call, please dial:

Finland: +358 9 817 103 10
Sweden: +46 8 566 426 51
UK: +44 333 300 0804
USA: +1 631 913 1422

PIN: 15315273#

Upcoming events

Annual General Meeting 2022	Planned to be held on Wednesday 23 March 2022
Interim Report January-March 2022	Thursday 28 April 2022
Half-Year Financial Report January-June 2022	Friday 15 July 2022
Interim Report January-September 2022	Thursday 20 October 2022

The Financial Statements and the Report of the Board of Directors for 2021 will be published on the Company's website at the latest in week 9/2022.

Espoo, 10 February 2022

Board of Directors of Orion Corporation

Orion Corporation

For additional information about the report:

Jari Karlson, CFO                 tel. +358 50 966 2883
Tuukka Hirvonen, Investor Relations        tel. +358 10 426 2721 or +358 50 966 2721

www.orion.fi/en/investors

Publisher:
Orion Corporation
http://www.orion.fi/en
http://www.twitter.com/OrionCorpIR

Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are neurological disorders, oncology and respiratory diseases for which Orion develops inhaled pulmonary medication. Orion's net sales in 2021 amounted to EUR 1,041 million and the company had about 3,350 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki.

Attachment

• Orion Financial Statement Release for 2021